BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADMINISTRATION SET

    MDR report key: 2900779 · Received December 14, 2012

    Report

    Report Number
    2025816-2012-00073
    Event Type
    Other
    Date Received
    December 14, 2012
    Date of Event
    January 27, 2012
    Report Date
    January 27, 2012
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    (B)(6) RECEIVED REPORTING OCCLUSION/FLOW ISSUES WITH USE OF B3004H 40" 4.6ML 20 DROP ADMIN SET. THE UFMW STATES" .. SECONDARY TUBING DID NOT INFUSE FLUSH AFTER CHEMOTHERAPY ADMINISTRATION. MANUAL FLUSH OF CHEMOTHERAPY." THERE WERE NO REPORTED ADVERSE CONSEQUENCES. ALTHOUGH REQUESTED, ADD'L INCIDENT INFO AND DEVICE RETURN REQUESTS HAVE TO DATE BEEN UNSUCCESSFUL. MFR'S ANALYSIS: A REVIEW OF THE MFG LOT DATABASE FOR LOT # 2405483 (MFG. DATE 11/2011) SHOWS 3000 UNITS WERE MFG TESTED, INSPECTED AND RELEASED. THE LOT BUILD RECORDS SHOWED ALL VISUAL, DIMENSIONAL AND FUNCTIONAL QC LOT TESTING MET ALL SPECS. THERE WERE NO EXCEPTION OR REJECTION DOCUMENTS GENERATED DURING THE BUILD. CONCLUSION: THE INVOLVED DEVICE WAS NOT RETURNED FOR ANALYSIS AND INVESTIGATION. CAUSE OF THE REPORTED INCIDENT REMAINS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADMINISTRATION SET ADMINISTRATION SET FPA ICU MEDICAL, INC. B3004H 2405483

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO Other